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Rapid antigen test reduces antibiotic use in adult sore throat

Clinical question What is the best strategy for diagnosing strep throat in adults?

Bottom line The use of a rapid antigen test reduces antibiotic use in adults with sore throat better than usual care and better than the use of a clinical decision rule alone. A combined approach using a clinical decision rule plus a rapid antigen test when the clinical rule is equivocal may be the most efficient approach. (Level of evidence = 1b)

Synopsis Sore throat is among the most common problems seen in primary care practices, and it is evaluated using a variety of strategies. In this study, 37 Canadian family doctors were asked to recruit 20 successive adults with sore throat. The physicians were randomized to use 1 of 4 strategies: usual clinical practice, decision rule only, rapid antigen test only, and clinical decision rule plus rapid antigen test if the decision rule was equivocal. The clinical decision rule was based on the well-validated Centor rule, with one assigned point each for fever, swollen glands, absence of cough, and tonsillar exudate, and one point subtracted for presence of cough. Interpretation of the rule was as follows: Antibiotics were not recommended for a patient with less than two points; antibiotics were recommended for a patient with three or four points; and no recommendation was made if a patient had two points.

Between 102 and 170 patients were recruited into each arm and 47% of all patients received a prescription for an antibiotic. The percentage of visits resulting in an antibiotic prescription was 27% for rapid antigen test alone; 38% for clinical decision rule plus rapid antigen test; 55% for clinical rule only; and 58% for usual practice. The difference between the two rapid antigen groups and the usual care group was statistically significant, but the difference between clinical rule plus rapid antigen test and the rapid antigen test alone was not.

We are not told how many patients had the rapid antigen test in the combined approach group, but presumably it was fewer than in the group where all patients received rapid antigen testing. We are also not told clinical outcomes such as the percentage of patients cured at 2 weeks or the percentage returning because of treatment failure.

Worrall G, Hutchinson J, Sherman G, Griffiths J. Diagnosing streptococcal sore throat in adults: randomized controlled trial of in-office aids. Can Fam Physician. 2007;53:666-671.

Sertraline is ineffective for hot flushes

Clinical question Is sertraline an effective treatment for menopausal hot flushes?

Bottom line Sertraline is no better than placebo for the treatment of menopausal hot flushes. (Level of evidence = 1b)

Synopsis This was a well-designed clinical trial of sertraline versus placebo for the treatment of hot flushes in perimenopausal or postmenopausal women (n = 99), aged 40 to 60 years, who reported at least 14 hot flushes per week. Dosing in the sertraline arm was 50 mg/d for the first 2 weeks, increasing to 100 mg/d for 4 more weeks if no substantial side effects were noted. Randomization was stratified according to menopausal status; ie, whether the woman had her last menstrual period within the past year. A daily hot flush score was calculated as frequency multiplied by severity. After 6 weeks of treatment hot flush frequency decreased similarly in the sertraline and placebo groups: 39% and 38%, respectively. There was likewise no significant difference in mean hot flush scores.

Grady D, Cohen B, Tice J, et al. Ineffectiveness of sertraline for treatment of menopausal hot flushes. Obstet Gynecol. 2007;109(4):823-830.

High-protein, low-carb diet is associated with increased mortality in women

Clinical question Is a diet high in protein and low in carbohydrates beneficial to women's health?

Bottom line There is an association between women's mortality risk and a diet that is low in carbohydrates, high in protein, or both. The strength of this association is reinforced by a dose-response gradient in the observations, as well as the additive effects of low carbohydrates and high protein. (Level of evidence = 2b)

Synopsis The Women's Lifestyle and Health Study is a Swedish cohort study of more than 42,000 women aged 30 to 49 years at the time of enrollment (1991-1992) and traced through national registries. The data collected at baseline included medical history; self-rated anthropometry and health status; and detailed information regarding lifestyle, including diet and physical activity. This study assessed mortality from enrollment through the end of 2003. The dietary information was scored regarding self-reported carbohydrate and protein intake from low to high, then ranked in deciles.

Mortality followed expected patterns for risk related to age, smoking, heavy alcohol use, body mass index, physical activity, and education. Regression modeling to control for such confounders was performed. Percentage of energy intake ranged from 32% to 72% for carbohydrates and 10% to 23% for protein. All-cause mortality increased by 6% with each decile below the mean for carbohydrate intake, by 2% with each decile above the mean for protein intake, and additively for both for women aged 40 to 49 years at enrollment. The data were not presented in a form to determine the increases in absolute mortality risk.

Lagiou P, Sandin S, Weiderpass E, et al. Low carbohydrate-high protein diet and mortality in a cohort of Swedish women. J Intern Med. 2007;261(4):366-374.

Adding methotrexate to sulfasalazine is better for rheumatoid arthritis

Clinical question In patients with rheumatoid arthritis (RA) who do not respond to sulfasalazine, does adding methotrexate provide better outcomes than either drug used alone?

Bottom line In patients with RA treated with sulfasalazine, adding methotrexate to sulfasalazine rather than replacing it produces better sustained outcomes, on average, with no difference in discontinuation due to side effects. As with most studies of RA, this study is small and the patients were heterogeneous. (Level of evidence = 1b)

Synopsis These Scottish investigators enrolled 687 patients with active RA from eight sites. All patients had RA for less than 10 years and a disease activity score (a combination of erythrocyte sedimentation rate, Ritchie articular index, swollen joint count, and patient assessment of disease activity) of 2.4 or higher. All patients were given sulfasalazine to a maximum tolerated dose, up to 4 g/d for 6 months. Patients with a disease activity score remaining at 2.4 or higher and who consented to remain in the study (n = 165) were then randomly assigned, using concealed allocation, to 1 of 3 groups: continued sulfasalazine with methotrexate, methotrexate with placebo sulfasalazine, or sulfasalazine with placebo methotrexate. The methotrexate dosing started at 7.5 mg/d and was increased monthly to a maximum dose of 25 mg/wk, although the average dose was 12.5 to 15 mg/wk. Over the next year, combination therapy decreased the disease activity scores by an average 0.67, which was significantly better than either drug used alone (0.3 reduction for continued sulfasalazine vs 0.26 reduction for methotrexate).

Using the European League Against Rheumatism Disease criteria, 18% achieved a good response and 10% achieved remission, which was approximately twice the rate in the other groups but not significantly better. Similarly, American College of Rheumatology scores were better with the combination, though not significantly so. These differences might have been significantly better if more patients were enrolled. Discontinuation of treatment because of side effects after the initial 6 months was approximately 25% to 30% in all three groups.

Capell HA, Madhok R, Porter DR, et al. Combination therapy with sulfasalazine and methotrexate is more effective than either drug alone in patients with rheumatoid arthritis with a suboptimal response to sulfasalazine: results from the double-blind placebo-controlled MASCOT study. Ann Rheum Dis. 2007;66(2):235-241.

Sustained-release ropinirole improves symptoms in advanced Parkinson's

Clinical question Does sustained-release ropinirole, as adjunctive therapy to levodopa, improve symptoms in patients with advanced Parkinson's disease?

Bottom line Sustained-release ropinirole is better than placebo for decreasing dyskinesia in patients whose advanced Parkinson's disease is not adequately controlled on levodopa. We don't know if this drug is better than any others, including shorter-acting ropinirole. (Level of evidence = 2b)

Synopsis In this industry-sponsored study, nearly 400 patients with advanced Parkinson's disease not adequately controlled on levodopa were randomly assigned to receive placebo or sustained-release ropinirole. Patients taking other medications could also be included as long as the doses were stable for at least 4 weeks before enrollment. The study continued for 24 weeks. The patients were started on 2 mg ropinirole per day. The dose was increased at subsequent visits, based on response, from a minimum dose of 6 mg/d to a maximum dose of 24 mg/d. The authors used an intention-to-treat analysis to compare outcomes, including the main outcome of “off” time (defined as those times when Parkinson's symptoms resulted in a lack of mobility). At the beginning of the study, patients in each group had approximately 7 hours of off time per day. At the end of the study patients taking ropinirole had approximately 1.7 fewer hours of off time than patients taking placebo. The authors state that 1.2 hours per day was clinically important. Nearly two-thirds of patients taking ropinirole experienced adverse events compared with approximately half of those taking placebo (mostly nausea, dyskinesia, sedation, and dizziness). The pooled drop-out rate, the least biased way of evaluating overall adverse effects and benefit, was 17% for those taking ropinirole and 29% for those taking placebo.

Be careful interpreting these kinds of studies. Because short-acting ropinirole is widely available, it is possible that this study is really an attempt to develop data to extend the patent. A better study would have compared sustained-release ropinirole with the shorter-acting version.

Pahwa R, Stacy MA, Factor SA, et al; EASE-PD Adjunct Study Investigators. Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease. Neurology. 2007;68(14):1108-1115.

PCI plus optimal medical treatment is effective for stable CAD

Clinical question Do percutaneous coronary interventions (PCIs) improve outcomes when added to optimal medical therapy in patients with stable coronary disease?

Bottom line Optimal medical therapy (treatment with a statin, an antiplatelet agent, an antianginal medication, and an ACE inhibitor or angiotensin receptor blocker) is as effective as PCIs followed by optimal medical therapy for patients with chronic stable coronary artery disease (CAD). (Level of evidence = 1b)

Synopsis The indications for PCI have broadened considerably since its introduction in the 1970s. However, guidelines still recommend optimal medical therapy as the first-line treatment for stable CAD, and studies have not shown a benefit of PCI in this population. Nevertheless, 85% of patients undergoing PCI each year have stable CAD as the indication. In this study, the largest to date, 2,287 patients with stable angina were randomly assigned to receive intensive medical therapy or PCI followed by intensive medical therapy. All had at least one proximal vessel with 70% stenosis and evidence of myocardial ischemia (95% of patients) or at least one proximal vessel with 80% stenosis accompanied by classic angina without provocative testing. Patients with persistent class IV angina, heart failure, recent revascularization, anatomy not suitable for PCI, or a markedly positive stress test result were excluded. Intensive medical therapy consisted of aspirin or clopidogrel; metoprolol, amlodipine, and/or isosorbide mononitrate; and lisinopril or losartan. Simvastatin with or without ezetimibe was used to achieve a target LDL level of less than 85 mg/dL (2.2 mmol/L). Exercise, extended-release niacin, and/or fibrates were used to achieve a HDL level of more than 40 mg/dL (1.03 mmol/L) and a triglyceride level of less than 150 mg/dL (1.67 mmol/L). Most patients did not receive a drug-eluting stent. The mean age of patients was 61 years, 85% were men, and 86% were white. Groups were balanced at the start of the study, analysis was by intention-to-treat, and patients were followed up for a mean of 4.6 years. Outcomes were assessed by researchers blinded to treatment assignment. All but 46 of 1,149 patients in the PCI group received the intervention; of those receiving a stent, 41% received more than one. Medical therapy was similarly intensive in both groups; for example, 70% in each group achieved their target LDL. Only 9% of patients were lost to follow-up in each group. The primary outcome was a composite of death or nonfatal MI. There was no difference between groups (19% in each) and also no significant difference in the likelihood of all-cause mortality (8% in each group). Patients in the medical therapy group were more likely to require revascularization during the study (33% vs 21%; P < .001; number needed to treat to harm = 8). Of course, the total number of revascularizations was much higher in the PCI group if you include the initial PCIs.

Boden WE, O'Rourke RA, Teo KK, et al; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356(15):1503-1516.

Levels of evidence in Bottom line are explained at www.infopoems.com/levels.html.